跳至主要内容
临床试验/NCT03083938
NCT03083938Unknown不适用

Prospective Randomized Controlled Trial of Omental Roll-up Technique on Pancreato-jejunostomy Anastomosis for Reducing Perioperative Complication in Patients Undergoing Pancreatoduodenectomy

Mahidol University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Complication rate after using omental roll-up technique

研究概览

简要总结

Despite the fact that pancreatoduodenectomy is the standard treatment of malignant tumor at periampullary area, the morbidity and mortality rate with intra-abdominal collection, post pancreatectomy hemorrhage, and delayed gastric emptying, is still high at approximately 50-60%. The causes of these complications usually come from post-operative pancreatic fistula. Nowadays, several methods have been reported to reduce the incidence of pancreatic fistula after undergoing pancreatoduodenectomy, such as pancreatic stenting, the use of intravenous somatostatin, the use of sealant material and wrapping anastomosis by soft tissue.

Wrapping pancreato-jejunal anastomosis with omentum is not a complicate procedure and requires no extra treatment expenses of the patient. It has been reported this technique has been applied in the non-randomized controlled trials and their data have significantly shown that the technique could reduce pancreatic fistula rate. Therefore, the researchers want to conduct an RCT study to compare complication rates between omental roll-up pancreato-jejunal anastomosis and non-omental roll-up groups.

详细描述

This is a RCT study designed to compare the use of omental roll-up technique with non-omental roll-up technique at pancreato-jejunal anastomosis in patients undergoing pancreatoduodenectomy. The purpose of this study is to prove the hypothesis that omental roll-up technique can reduce the complication rate or pancratic fistula after pancreatoduodenectomy. This study was approved by the committee on human rights to conduct the research involving human subjects, faculty of medicine Ramathibodi hospital, Mahidol university. The patients are operated by experienced surgeons of Hepato-pancreato-biliary unit, department of surgery, Ramathibodi hospital and randomized into two groups by using the closed envelope method after completing pancreato-jejunal anastomosis. Then, patients are followed-up and the data are collected for 30 days after the surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing pancreatoduodenectomy from these disease, carcinoma at head of pancreas, carcinoma at ampullar of Vater, Distal cholangiocarcinoma, Carcinoma of duodenum

排除标准

  • Unresectable pancreatoduodenectomy
  • Patients underwent omentectomy from prior surgery

研究组 & 干预措施

Omental Roll-up

Experimental

干预措施: Omental Roll-up (Procedure)

No Omental Roll-up

No Intervention

结局指标

主要结局

Complication rate after using omental roll-up technique

时间窗: Within 30 days after surgery

Complication rate after using omental roll-up technique compare with non-omental roll-up

次要结局

  • Pancreatic fistula rate after using omental roll-up technique(Within 30 days after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paramin Muangkaew, MD

Principal Investigator

Mahidol University

研究点 (2)

Loading locations...

相似试验